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A Study to Evaluate Lebrikizumab (MILR1444A) in Adult Patients With Asthma Who Are Not Taking Inhaled Corticosteroids

NCT ID: NCT00971035

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-02-28

Brief Summary

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This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.

Detailed Description

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Conditions

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Asthma

Keywords

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MILR1444A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type EXPERIMENTAL

lebrikizumab (MILR1444A)

Intervention Type DRUG

Subcutaneous repeating dose

B

Group Type EXPERIMENTAL

lebrikizumab (MILR1444A)

Intervention Type DRUG

Subcutaneous repeating dose

C

Group Type EXPERIMENTAL

lebrikizumab (MILR1444A)

Intervention Type DRUG

Subcutaneous repeating dose

D

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Subcutaneous repeating dose

Interventions

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lebrikizumab (MILR1444A)

Subcutaneous repeating dose

Intervention Type DRUG

lebrikizumab (MILR1444A)

Subcutaneous repeating dose

Intervention Type DRUG

lebrikizumab (MILR1444A)

Subcutaneous repeating dose

Intervention Type DRUG

placebo

Subcutaneous repeating dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight ≥ 50 kg and ≤ 150 kg at Visit 1
* Chest radiograph within 12 months of Visit 1 without evidence of a clinically significant abnormality
* Stable asthma

Exclusion Criteria

* Asthma exacerbation during screening
* Known malignancy
* Known immunodeficiency
* Pre-existing lung disease other than asthma
* Uncontrolled clinically significant medical disease
* Current smoker
* History of substance abuse that may impair or risk the patient's full participation in the study, in the judgment of the investigator
* Prior allergic reaction to a monoclonal antibody
* Patients (men and women) of reproductive potential who are not willing to use contraception
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Freemer, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

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Hungary Poland Russia South Africa United States

Other Identifiers

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ILR4660g

Identifier Type: -

Identifier Source: org_study_id